Sch 2retail licence means a licence of a type referred to in item 2 of the Table to regulation 74(2).

Schedule 2 retail licence means a licence of a type referred to in item 2 of the Table to regulation 74(2). (2) A medicine that is a Schedule 2 poison that is stored for supply by retail sale must be stored — (a) in premises specified in a Schedule 2 retail licence or in a pharmacy; and (b) in an area or in a manner that prevents physical access to the medicine by any person other than a person who is employed in the pharmacy or employed by the licensee. (3) A medicine that is a Schedule 2 poison that is stored other than for supply by retail sale must be stored — (a) so that it is not visible to members of the public; and (b) in an area or in a manner that prevents physical access to the medicine by members of the public. ### Division 3 — Requirements for medicine that is Schedule 3 poison ##### 87. Storage of medicine that is Schedule 3 poison (1) A medicine that is a Schedule 3 poison that is stored for supply by retail sale must be stored — (a) in a pharmacy; and (b) in an area or in a manner that prevents physical access to the medicine by any person other than a person who is employed in the pharmacy. (2) A restricted Schedule 3 poison must not be stored in any part of the retail area of a pharmacy. (3) A medicine that is a Schedule 3 poison that is stored other than for supply by retail sale must be stored — (a) so that it is not visible to members of the public; and (b) in an area or in a manner that prevents physical access to the medicine by members of the public. ##### 88. Supply by retail sale of medicine that is Schedule 3 poison pharmacy intern means a person who is undertaking supervised practice approved by the Pharmacy Board of Australia; pharmacy technician means a person who assists a pharmacist in the preparation, dispensing and supply of medicines. (2) A medicine that is a Schedule 3 poison must not be supplied by retail sale unless it is supplied — (a) personally by a pharmacist; or (b) by a pharmacy intern under the personal supervision of a pharmacist; or (c) by a pharmacy technician under the personal supervision of a pharmacist. (3) A restricted Schedule 3 poison must not be supplied by retail sale in a pharmacy unless the identity of the purchaser — (a) is known to the pharmacist, intern or technician; or (b) is verified by the pharmacist, intern or technician by means of photographic evidence provided by the purchaser. (4) A restricted Schedule 3 poison that is supplied by retail sale must be labelled with — (a) the name and address of the pharmacy from which it is supplied; and (b) the number or code allocated under regulation 142(2)(b). ##### 89. Advertising medicine that is Schedule 3 poison Australian Register of Therapeutic Goods means the register maintained under the *Therapeutic Goods Act 1989* (Commonwealth) section 9A; listed name, in relation to a medicine that is a Schedule 3 poison, means a name of the medicine that is listed in the Australian Register of Therapeutic Goods. (2) A medicine that is a Schedule 3 poison must not be advertised unless the advertisement is in a publication that is normally sold or intended for sale or circulation only to health professionals or persons licensed to manufacture or supply medicines. (3) Subregulation (2) does not apply to a medicine that is listed in the current Poisons Standard Appendix H and advertised by its listed name. [Regulation 89 amended: SL 2023/3 r. 7.] ### Division 4 — Requirements for medicine that is Schedule 4 poison ##### 90. Storage of medicine that is Schedule 4 poison (1) A medicine that is a Schedule 4 poison must be stored for supply by retail sale — (a) in a pharmacy; and (b) in an area or in a manner that prevents physical access to the medicine by any person other than a person who is employed in the pharmacy. (2) A medicine that is a Schedule 4 poison supplied to an authorised health professional for the purposes of administration or supply in accordance with a professional authority must be stored at the health professional’s usual place of practice in a container, cabinet or room that — (a) is kept locked; and (b) is accessible only by an authorised health professional or a person who is personally supervised by an authorised health professional. (3) However, an authorised health professional who attends patients at a place other than the health professional’s usual place of practice may carry a medicine that is a Schedule 4 poison for the purpose of treatment of those patients if — (a) the quantity of the medicine carried is an amount reasonably required by the health professional for the treatment of the patients; and (b) the medicine is in the possession of the health professional at all times; and (c) the health professional takes reasonable steps to protect the medicine from being lost or stolen. ##### 91. Advertising medicine that is Schedule 4 poison A medicine that is a Schedule 4 poison must not be advertised unless the advertisement is in a publication that is normally sold or intended for sale or circulation only to health professionals or persons licensed to manufacture or supply medicines. ### Division 5 — Requirements for Schedule 5, 6 or 7 poison ##### 92. Storage, transport and disposal of Schedule 5, 6 or 7 poison A Schedule 5, 6 or 7 poison must be stored, transported and disposed of in accordance with the current Poisons Standard Part 2. [Regulation 92 amended: SL 2023/3 r. 7.] ##### 93. Manufacture and supply of Schedule 5, 6 or 7 poison (1) A Schedule 5, 6 or 7 poison must be manufactured and supplied in accordance with the current Poisons Standard Part 2. (2) A Schedule 5, 6 or 7 poison must not be supplied to a person who is apparently under 16 years of age. [Regulation 93 amended: SL 2023/3 r. 7.] ### Division 6 — Requirements for medicine that is Schedule 8 poison or for Schedule 9 poison #### Subdivision 1 — Preliminary ##### 94. Terms used approved alternative storage arrangement means an arrangement approved by the CEO under regulation 102; AS/NZS 3809:1998 means Australian/New Zealand Standard 3809:1998 *Safes and strongrooms* jointly published by Standards Australia and Standards New Zealand; detection device, in relation to a safe or strongroom, means a continuously monitored system — (a) to detect the presence of a person who interferes, or attempts to interfere, with a safe or strongroom or any security measures associated with the safe or strongroom; and (b) that complies with the requirements in AS 2201.3‑1991 *Intruder alarm systems, Part 3:* *Detection devices for internal use* published by Standards Australia; dose, in relation to a medicine that is a Schedule 8 poison, means — (a) an individual human dose of the medicine in the form of a tablet, capsule, ampoule, vial or sachet or in a similar form; or (b) if the medicine is not in a form referred to in paragraph (a) — an amount that is equivalent to the smallest available individual human dose of the medicine; large safe means a safe — (a) that — (i) is determined in accordance with AS/NZS 3809:1998 to have a resistance grading of at least II; or (ii) complies with the requirements for a large safe set out in the Table to Schedule 3 clause 2 of these regulations; and (b) that is kept locked at all times except when items are being placed in or removed from it; and (c) that is located in an area that is not accessible by members of the public; secure cabinet means a cupboard or drawer that — (a) is made from hardwood or metal; and (b) is lockable; and (c) is securely fixed to a floor or wall; and (d) is kept locked at all times except when items are being placed in or removed from it; small safe means a safe — (a) that is — (i) determined in accordance with AS/NZS 3809:1998 to have a resistance grading of at least I; or (ii) complies with the requirements for a small safe set out in the Table to Schedule 3 clause 1 of these regulations; and (b) that is kept locked at all times except when items are being placed in or removed from it; and (c) that is located in an area that is not accessible by members of the public; strongroom means a strongroom that is determined in accordance with AS/NZS 3809:1998 to have a resistance grading of at least VII. #### Subdivision 2 — Requirements for medicine that is Schedule 8 poison ##### 95. Storage and carriage of medicine that is Schedule 8 poison: authorised health professional or permit holder relevant premises means any of the following — (a) premises, other than a hospital or a pharmacy, at which an authorised health professional carries out the lawful practice of their profession; (b) premises that are specified in a permit that authorises the use of a medicine that is a Schedule 8 poison. (2) A medicine that is a Schedule 8 poison stored at relevant premises must be stored as follows — (a) if there are not more than 250 doses of medicines that are Schedule 8 poisons stored at the premises — (i) in a small safe; or (b) if there are more than 250 doses but not more than 500 doses of medicines that are Schedule 8 poisons stored at the premises — (i) in a small safe with a detection device; or (c) if there are more than 500 doses of medicines that are Schedule 8 poisons stored at the premises — (i) in a large safe with a detection device; or (ii) in accordance with an approved alternative storage arrangement. (3) An authorised health professional who attends patients at a place other than the health professional’s usual place of practice may carry a medicine that is a Schedule 8 poison for the purpose of treatment of those patients if — (a) the quantity of the medicine carried is a quantity reasonably required by the health professional for the treatment of the patients; and (b) the medicine is in the possession of the health professional at all times; and (c) the health professional takes reasonable steps to protect the medicine from being lost or stolen. ##### 96. Storage of medicine that is Schedule 8 poison: pharmacy (1) A medicine that is a Schedule 8 poison stored in a pharmacy or the pharmacy department of a hospital must be stored — (a) in a secure cabinet access to which is supervised at all times by a pharmacist; or (b) in a large safe with a detection device; or (c) in accordance with an approved alternative storage arrangement. (2) A pharmacist who is supervising access to a secure cabinet in which a medicine that is a Schedule 8 poison is stored must — (a) if access to the secure cabinet is by use of a key — keep immediate and personal possession of the key; or (b) if access to the secure cabinet is by way of an access code — take all reasonable measures to ensure that the access code is not given to any other person. ##### 97. Storage of medicine that is Schedule 8 poison: hospital (1) A medicine that is a Schedule 8 poison stored at a hospital must be stored — (a) in the pharmacy department of the hospital in accordance with regulation 96; or (b) in a ward or patient care location in the hospital as follows — (i) when the ward or patient care location is being supervised by an authorised health professional — in a secure cabinet; (ii) when the ward or patient care location is not supervised by an authorised health professional — in accordance with subregulation (2). (2) A medicine that is a Schedule 8 poison stored in a ward or patient care location in a hospital when it is not supervised by an authorised health professional must be stored as follows — (a) if there are not more than 250 doses of medicines that are Schedule 8 poisons stored in the ward or patient care location — (i) in a small safe; or (b) if there are more than 250 doses but not more than 500 doses of medicines that are Schedule 8 poisons stored in the ward or patient care location — (i) in a small safe with a detection device; or (c) if there are more than 500 doses of medicines that are Schedule 8 poisons stored in the ward or patient care location — (i) in a large safe with a detection device; or (ii) in accordance with an approved alternative storage arrangement. (3) An authorised health professional who is supervising a ward or patient care location in a hospital in which a medicine that is a Schedule 8 poison is stored in a secure cabinet must — (a) if access to the secure cabinet is by use of a key — keep immediate and personal possession of the key; or (b) if access to the secure cabinet is by way of an access code — take all reasonable measures to ensure that the access code is not given to any other person. ##### 98. Storage of medicine that is Schedule 8 poison: licensed premises A medicine that is a Schedule 8 poison stored on premises that are specified in a wholesaler’s/manufacturer’s licence must be stored — (a) in a strongroom with a detection device; or (b) in accordance with an approved alternative storage arrangement. ##### 99. Packaging medicine that is Schedule 8 poison for transport A medicine that is a Schedule 8 poison that is transported for commercial purposes must be transported in a package — (a) that does not contain goods other than medicines that are Schedule 8 poisons; and (b) that is secure and sturdy without any exterior writing that might indicate the contents of the package; and (c) that is clearly addressed to a person who is authorised to be in possession of the medicine. ##### 100. Advertising medicine that is Schedule 8 poison A medicine that is a Schedule 8 poison must not be advertised unless the advertisement is in a publication that is normally sold or intended for sale or circulation only to health professionals or persons licensed to manufacture or supply medicines. #### Subdivision 3 — Requirements for Schedule 9 poison ##### 101. Storage of Schedule 9 poison A Schedule 9 poison must be stored — (a) in a large safe with a detection device; or (b) in accordance with an approved alternative storage arrangement. #### Subdivision 4 — Approval of alternative storage arrangement ##### 102. Approval of alternative storage arrangement for medicine that is Schedule 8 poison or for Schedule 9 poison (1) The CEO may, by notice given to a person who stores a Schedule 9 poison or a medicine that is a Schedule 8 poison, approve an arrangement for the storage of the poison or medicine if the CEO is satisfied that the arrangement provides for the secure storage of the poison or medicine. (2) The approval — ### Division 7 — Vending machines ##### 103. Supply of medicine from vending machine For the purposes of section 24(2), a medicine may be supplied from a vending machine that has been placed in premises in accordance with regulation 104 if the person who removes the medicine from the machine — (a) is authorised to access the machine; and (b) has gained access to the machine in accordance with the procedures for access to the machine referred to in regulation 105(5)(a). ##### 104. Placement of vending machine For the purposes of section 24(4), a vending machine may be placed in premises if — (a) the premises — (i) are premises at which an authorised health professional carries out the lawful practice of their profession; or (ii) are specified in a licence or permit; and (b) the placement of the vending machine is approved by the CEO under regulation 105(4). ##### 105. Approval of placement of vending machine (1) A person may apply to the CEO for approval to place a vending machine in premises. (2) An application must be in an approved form. (4) The CEO may approve the placement of a vending machine in premises if satisfied that — (a) the machine is sufficiently secure; and (b) the machine is designed so that, to the extent practicable, for any particular medicine, only an authorised health professional who has authority to administer or supply the medicine can access the machine to remove the medicine; and (c) the proposed placement complies with any other criteria the CEO thinks relevant. (5) The CEO cannot be satisfied that a vending machine is sufficiently secure unless satisfied that, to the extent practicable — (a) access to the machine to remove any particular medicine from the machine is controlled by appropriate procedures; and (b) only persons permitted to have access to the machine according to those procedures can have access to the machine for the purpose of removing a particular medicine from the machine; and (c) every occurrence of the removal, or attempted removal, of a medicine from the machine is recorded electronically by the machine in a way that cannot be amended or erased. (6) Subregulation (5) does not limit the matters the CEO may take into account for the purposes of subregulation (4). ### Division 8 — Miscellaneous ##### 106. CEO to be notified of loss or theft of certain poisons A person who is an authorised health professional, a licensee or a permit holder must, as soon as is reasonably practicable, notify the CEO in writing if — (a) the person loses a Schedule 7 or 9 poison or a medicine that is a Schedule 4 or 8 poison; or (b) a Schedule 7 or 9 poison or a medicine that is a Schedule 4 or 8 poison is stolen from the person. Penalty: a fine of $5 000. ##### 107. CEO may give direction about storage or use of poison specified means specified in a direction. (2) If the CEO is satisfied that a person is storing or using a poison in a manner that may cause a serious danger to public health, the CEO may direct the person — (a) to secure the poison in a specified place and by specified means and not to remove the poison until further directed by the CEO; or (b) to destroy, or otherwise dispose of, the poison in a specified way; or (c) not to use the poison (either generally or in a specified way); or (d) to deliver the poison to a specified person at a specified time and place. (3) The direction — (4) A person must comply with a direction given under subregulation (2). ## Part 10 — Needle and syringe programmes ##### 108. Approval of needle and syringe programme (1) A person may apply to the CEO for approval of a needle and syringe programme. (2) An application must — (a) be in an approved form; and (b) nominate a person to be the coordinator of the programme. (4) An approval of a needle and syringe programme must — (a) be given by written notice signed by the CEO; and (b) clearly identify the programme that is being approved by reference to the activity or activities, and the persons or class of persons engaging in the activity or activities, that constitute the programme; and (c) specify the period during which the programme is approved; and (d) specify any conditions that apply to the approval. (5) The CEO must not approve a needle and syringe programme unless the CEO is satisfied that the coordinator of the programme — (a) is at least 18 years of age; and (b) is a person of good character and repute; and (c) is a fit and proper person to coordinate the programme; and (d) understands their duties as the coordinator of the programme. ##### 109. Copy of approval to be provided to programme coordinator The CEO must give a copy of the notice of approval to the coordinator of the approved needle and syringe programme. ##### 110. Condition of approval: programme coordinator’s duties The approval of a needle and syringe programme is subject to the condition that the coordinator of the programme must — (a) keep a register of all persons engaged in the conduct of the programme; and (b) ensure that persons engaged in the conduct of the programme understand the requirements of these regulations and are appropriately instructed and trained; and (c) submit to the CEO an annual report on the programme by a date specified by the CEO; and (d) report to the CEO any irregularities that occur in the conduct of the programme. ##### 111. Condition of approval: used needles and syringes (1) The approval of a needle and syringe programme is subject to the following conditions — (a) a used hypodermic needle or a used hypodermic syringe must not be accepted in the course of the conduct of the programme unless the needle or syringe has been exhausted; (b) a used hypodermic needle or a used hypodermic syringe received in the course of the conduct of the programme must be placed immediately in a receptacle of a type approved by the CEO. (2) For the purposes of subregulation (1)(a), a hypodermic needle or a hypodermic syringe is taken to have been exhausted if it contains no more than the residue of any Schedule 8 or 9 poison. ##### 112. Condition of approval: conduct of programme (1) The CEO may approve a needle and syringe programme subject to the condition that the programme only be conducted — (a) at a specified place or specified places; or (b) between specified times. (2) If the CEO is of the opinion that a person is not a suitable person to be engaged in the conduct of an approved needle and syringe programme, the CEO may, by written notice given to that person and to the coordinator of the programme, direct the person not to participate in the conduct of the programme. (3) The approval of a needle and syringe programme is subject to the condition that a person who has been given a direction under subregulation (2) must not participate in the conduct of the programme. ##### 113. Breach of condition of approval (1) The CEO may, by written notice given to the coordinator of an approved needle and syringe programme, revoke an approval given under regulation 108 in respect of the programme if the CEO is satisfied that a condition of the approval has been breached. (2) A person does not have possession of a used hypodermic needle, used hypodermic syringe or another used thing for the purpose of disposing of it in accordance with an approved needle and syringe programme if the possession by the person of the syringe, needle or other thing is in breach of a condition of the approval. ## Part 11 — Prescription and supply of medicines that are Schedule 4 reportable poisons or Schedule 8 poisons [Heading inserted: SL 2024/265 r. 15.] ##### 114. Terms used custodial facility means — (a) a prison as defined in the *Prisons Act 1981* section 3(1); or (b) a detention centre as defined in the *Young Offenders Act 1994* section 3; opioid pharmacotherapy means any of the following substances when used for the treatment of drug dependency — (a) methadone or buprenorphine; (b) any of the salts of methadone or buprenorphine; (c) any preparation or admixture containing methadone or buprenorphine or any of their salts; prescribing code means the *Monitored Medicines Prescribing Code* approved by the CEO and published on the Department’s website; stimulant means any of the following substances — (a) dexamfetamine, lisdexamfetamine or methylphenidate; (b) any of the salts of dexamfetamine, lisdexamfetamine or methylphenidate; (c) any preparation or admixture containing dexamfetamine, lisdexamfetamine or methylphenidate or any of their salts. [Regulation 114 amended: SL 2024/265 r. 16.] ##### 115. Application of Part This Part does not apply to dispensing a medicine that is a Schedule 4 reportable poison or a Schedule 8 poison. [Regulation 115 amended: SL 2024/265 r. 17.] ### Division 2 — General requirements ##### 116. Requirements for prescription or supply of medicine that is Schedule 4 reportable poison or Schedule 8 poison (1) This regulation does not apply to the prescription or supply of a medicine that is a Schedule 8 poison for the treatment of a patient who is a drug dependent person or an oversupplied person. (2) An authorised health professional may prescribe or supply a medicine that is a Schedule 4 reportable poison or a Schedule 8 poison for the treatment of a patient if — (a) the medicine is not a stimulant and the prescription or supply complies with the requirements for prescribing or supplying the medicine set out in the prescribing code; or [(b) deleted] (c) the medicine is a stimulant and the health professional is authorised under Division 4 to prescribe or supply the medicine and the prescription or supply is in accordance with the authorisation; or (d) the health professional is authorised under regulation 118 to prescribe or supply the medicine for the patient and the prescription or supply is in accordance with the authorisation. [Regulation 116 amended: SL 2024/265 r. 18.] ##### 117. Administration, prescription or supply of medicine that is Schedule 8 poison to drug dependent person or oversupplied person (1) An authorised health professional may administer a medicine that is a Schedule 8 poison for the treatment of a patient who is a drug dependent person or an oversupplied person. (2) An authorised health professional may prescribe or supply a medicine that is a Schedule 8 poison for the treatment of a patient who is a drug dependent person or an oversupplied person if — (a) the health professional is authorised under regulation 118 to prescribe or supply the medicine for the patient and the prescription or supply is in accordance with the authorisation; or (b) the health professional is authorised under Division 5 to prescribe the medicine for the purpose of treatment of drug dependence and the prescription or supply is in accordance with the authorisation. ##### 118. CEO may authorise prescribing of specified medicine that is Schedule 8 poison to specified patient specified means specified in an authorisation. (2) The CEO may, on the request of an authorised health professional, authorise the health professional to prescribe or supply a specified medicine that is a Schedule 8 poison for the treatment of a specified patient if the CEO is satisfied that it is reasonable to prescribe or supply the medicine for the patient. (3) The authorisation — (4) If an authorisation is given under subregulation (2), another authorised health professional may prescribe or supply the medicine in accordance with the authorisation if that health professional — (a) is a member of the same medical practice as the health professional to whom the authorisation was given; and (b) has access to the clinical records of the practice relating to the specified patient. [Division 3 (r. 119‑124) deleted: SL 2024/265 r. 19.] ### Division 4 — Authorising prescription or supply of stimulant ##### 125. Terms used clinic prescriber means a medical practitioner who practices at a stimulant clinic; stimulant clinic means a clinic approved under regulation 127(2); stimulant prescriber means a medical practitioner or a person within a class of medical practitioners designated under regulation 128(1). [Regulation 125 amended: SL 2024/265 r. 20.] ##### 126. Prescribing or supplying stimulant (1) A medical practitioner is authorised to prescribe or supply a stimulant for the treatment of a patient if — (a) the medical practitioner is — (i) a clinic prescriber; or (ii) a stimulant prescriber; and (b) the prescription or supply is in accordance with the requirements for the stimulant set out in the prescribing code. (2) If a medical practitioner has prescribed or supplied a stimulant for the treatment of a patient, an authorised health professional is authorised to prescribe or supply the stimulant for the continued treatment of the patient with the stimulant if — (a) the patient is under regular treatment with the stimulant by the medical practitioner; and (b) the medical practitioner has not made a notification under regulation 130(1A) in relation to the patient’s treatment with the stimulant; and (c) the health professional’s prescription or supply of the stimulant is in accordance with the requirements for the stimulant set out in the prescribing code; and (d) the health professional’s prescription or supply of the stimulant — (i) is in accordance with a written instruction from the medical practitioner to the health professional; or (ii) is consistent with the form and dosage of the stimulant previously prescribed or supplied by the medical practitioner for the treatment of the patient. (3) A medical practitioner whose practice includes treating patients who are patients in a hospital or in custody in a custodial facility is authorised to prescribe or supply a stimulant for the treatment of such a patient if — (a) the patient is under regular treatment with the stimulant; and (b) the prescription or supply is consistent with the form and dosage of that treatment; and (c) the medical practitioner is satisfied that it is safe to prescribe the stimulant for the patient; and (d) the prescription or supply is for treatment of the patient for a period that does not exceed 3 months. [Regulation 126 amended: SL 2024/265 r. 21.] ##### 127. Approval of stimulant clinic public health service facility has the meaning given in the *Health Services Act 2016* section 6. (2) The CEO may approve a public health service facility as a stimulant clinic if — (a) patients are treated with stimulants at the facility; and (b) there is at least one stimulant prescriber employed at the facility. (3) The approval — ##### 128. Designating stimulant prescriber (1) The CEO may designate — (a) a medical practitioner as a stimulant prescriber; or (b) a class of medical practitioners, and each person within that class is a stimulant prescriber. (2) The designation — (3) A designation under subregulation (1)(b), and any amendment, suspension or revocation under subregulation (2)(c), must be published as soon as is practicable on the Department’s website. [Regulation 128 amended: SL 2024/265 r. 22.] [**129.** Deleted: SL 2024/265 r. 23.] ##### 130. Stimulant prescriber to notify CEO if patient’s stimulant treatment stops (1) This regulation applies if a medical practitioner — (a) stops the treatment of a patient with a stimulant; and (b) considers that an authorisation under regulation 118 would be required to continue the treatment of the patient with the stimulant. (1A) The medical practitioner must notify the CEO as soon as is practicable in accordance with subregulation (2). (2) The notification must be in an approved form and include the following information — (a) the name, date of birth and address of the patient; (b) details of the type, form and dosage of the stimulant; (c) the reason the medical practitioner stopped the treatment of the patient with the stimulant. [Regulation 130 amended: SL 2024/265 r. 24.] [**131, 132.** Deleted: SL 2024/265 r. 25.] ### Division 5 — Authorising prescription or supply of opioid pharmacotherapy for treatment of drug dependency #### Subdivision 1 — Preliminary ##### 133. Terms used co‑prescriber, in relation to a patient, means a medical practitioner who is appointed as a co‑prescriber for the patient under regulation 138(1); current detoxification prescriber, in relation to a patient, means the current detoxification prescriber for the patient under regulation 136(1); detoxification prescriber means a medical practitioner designated as a detoxification prescriber under regulation 134(3); opioid pharmacotherapy prescriber means a medical practitioner or nurse practitioner designated as an opioid pharmacotherapy prescriber under regulation 134(1); specialist prescriber means an opioid pharmacotherapy prescriber designated as a specialist prescriber under regulation 134(2). ##### 134. Designation of opioid pharmacotherapy prescriber, specialist prescriber and detoxification prescriber (1) The CEO may designate a medical practitioner or a nurse practitioner as an opioid pharmacotherapy prescriber. (2) The CEO may designate an opioid pharmacotherapy prescriber as a specialist prescriber. (3) The CEO may designate a medical practitioner as a detoxification prescriber. (4) A designation under subregulation (1), (2) or (3) — #### Subdivision 2 — Detoxification treatment using opioid pharmacotherapy ##### 135. Detoxification treatment using opioid pharmacotherapy detoxification treatment means the use of opioid pharmacotherapy for the purpose of opiate withdrawal. (2) A medical practitioner is authorised to administer or supply an opioid pharmacotherapy for the purpose of detoxification treatment of a patient if the medical practitioner — (a) is a detoxification prescriber; and (b) does so in accordance with the requirements relating to detoxification treatment set out in the prescribing code. (3) A detoxification prescriber must notify the CEO before commencing detoxification treatment of a patient. (4) The notification must be in an approved form and include the following information — (a) the name, date of birth and address of the patient; and (b) details of the treatment provided. ##### 136. Current detoxification prescriber for patient (1) When the CEO receives a notification about a patient under regulation 135(3) from a detoxification prescriber, the prescriber giving the notification becomes the patient’s current detoxification prescriber. (2) When the CEO receives a notification about a patient under subregulation (1), the CEO must give written notice to — (a) any person who was the current detoxification prescriber for the patient immediately before the notification was received; and (b) any person who the CEO believes, on reasonable grounds has been, or may be, requested to administer or supply a medicine that is a Schedule 8 poison to the patient. (3) A person who is given a notice under subregulation (2) about a patient must not, without the written approval of the CEO, administer or supply a medicine that is a Schedule 8 poison for the treatment of the patient. #### Subdivision 3 — Opioid pharmacotherapy for treatment of drug dependency ##### 137. Appointing opioid pharmacotherapy prescriber for drug dependent person (1) The CEO may appoint an opioid pharmacotherapy prescriber to be the opioid pharmacotherapy prescriber for a patient who is a drug dependent person. (2) The appointment is for the period specified in the instrument of appointment. (3) The appointment — ##### 138. Appointing co‑prescriber for drug dependent person (1) A specialist prescriber who is the opioid pharmacotherapy prescriber for a patient who is a drug dependent person may appoint a medical practitioner (who need not be an opioid pharmacotherapy prescriber) to be a co‑prescriber for the patient. (2) The appointment — (a) is for the period specified in the instrument of appointment, which cannot be more than 12 months; and (b) ceases on the earlier of — (i) the end of the period of appointment; or (ii) the specialist prescriber ceasing to be the opioid pharmacotherapy prescriber for the patient. (3) The appointment — (c) may, at any time, be amended, suspended or revoked by the specialist prescriber. (4) A specialist prescriber who makes an appointment under subregulation (1) must, as soon as is reasonably practicable, give a copy of the appointment to the CEO. (5) A specialist prescriber must, on a written direction given to the prescriber by the CEO, suspend or revoke an appointment made under subregulation (1). Penalty for this subregulation: a fine of $2 000. (6) A specialist prescriber must notify a medical practitioner if any of the following occurs — (a) the prescriber appoints the medical practitioner as a co‑prescriber for a patient under subregulation (1); (b) the prescriber amends, suspends or revokes the appointment; (c) the prescriber has appointed the medical practitioner as a co‑prescriber for a patient and the prescriber ceases to be the opioid pharmacotherapy prescriber for the patient. ##### 139. Prescribing opioid pharmacotherapy for treatment of drug dependency (1) A medical practitioner or nurse practitioner is authorised to prescribe an opioid pharmacotherapy for the treatment of a patient who is a drug dependent person if — (a) the medical practitioner or nurse practitioner is appointed under regulation 137(1) as the opioid pharmacotherapy prescriber for the patient; and (b) the medical practitioner or nurse practitioner prescribes the opioid pharmacotherapy in accordance with the appointment; and (c) the prescription complies with the requirements for prescribing the opioid pharmacotherapy set out in the prescribing code. (2) A medical practitioner or nurse practitioner is authorised to prescribe an opioid pharmacotherapy for the treatment of a patient who is a drug dependent person if — (a) the medical practitioner or nurse practitioner is an opioid pharmacotherapy prescriber; and (b) the medical practitioner or nurse practitioner is a member of the same medical practice as the opioid pharmacotherapy prescriber appointed under regulation 137(1) for the patient; and (c) the medical practitioner or nurse practitioner has access to the clinical records of the practice relating to the patient; and (d) the medical practitioner or nurse practitioner prescribes the opioid pharmacotherapy in accordance with the appointment of the opioid pharmacotherapy prescriber for the patient; and (e) the prescription complies with the requirements for prescribing the opioid pharmacotherapy set out in the prescribing code. (3) A medical practitioner is authorised to prescribe an opioid pharmacotherapy for the treatment of a patient who is a drug dependent person if — (a) the medical practitioner is a co‑prescriber for the patient; and (b) the medical practitioner prescribes the opioid pharmacotherapy in accordance with — (i) the appointment as a co‑prescriber; and (ii) the appointment of the opioid pharmacotherapy prescriber for the patient; and (c) the prescription complies with the requirements for prescribing the opioid pharmacotherapy set out in the prescribing code. (4) A prescription for the supply of an opioid pharmacotherapy under subregulation (3) must not cover a period of more than 3 months. ##### 140. Prescribing opioid pharmacotherapy for treatment of drug dependent person in hospital or custody (1) A medical practitioner whose practice includes treating drug dependent persons who are patients in a hospital or in custody in a custodial facility is authorised to prescribe an opioid pharmacotherapy for the treatment of such a patient if — (a) an opioid pharmacotherapy prescriber is appointed under regulation 137(1) for the patient; and (b) the medical practitioner is satisfied that it is safe to prescribe an opioid pharmacotherapy for the patient; and (c) the medical practitioner prescribes the opioid pharmacotherapy in accordance with the appointment of the opioid pharmacotherapy prescriber for the patient; and (d) the prescription complies with the requirements for prescribing the opioid pharmacotherapy set out in the prescribing code; and (e) the prescription is for the treatment of the patient for a period that does not exceed 1 month. (2) Subregulation (1) does not authorise the medical practitioner to prescribe an opioid pharmacotherapy unless it will be administered to a person while the person is a patient in the hospital or in custody in the custodial facility. ##### 141. Prescribing opioid pharmacotherapy for treatment of drug dependent person in certain circumstances (1) A specialist prescriber is authorised to prescribe an opioid pharmacotherapy for the treatment of a patient who is a drug dependent person if — (a) an opioid pharmacotherapy prescriber is appointed under regulation 137(1) for the patient; and (b) the specialist prescriber — (i) is satisfied that the patient is unable to obtain a prescription for an opioid pharmacotherapy under regulation 139 or 140; and (ii) is satisfied that it is safe to prescribe an opioid pharmacotherapy for the treatment of the patient; and (iii) does so in accordance with the appointment of the opioid pharmacotherapy prescriber for the patient; and (c) the prescription complies with the requirements for prescribing the opioid pharmacotherapy set out in the prescribing code; and (d) the prescription is for the treatment of the patient for a period that does not exceed 1 month. (2) A specialist prescriber who prescribes an opioid pharmacotherapy for the treatment of a patient under subregulation (1) must, as soon as is reasonably practicable, notify the CEO and the opioid pharmacotherapy prescriber appointed for the patient. ## Part 12 — Record keeping and reporting ##### 142. Record of supply by retail sale of medicine that is restricted Schedule 3 poison approved system means a recording system approved in writing by the CEO for the purposes of this regulation. (2) A pharmacist who supplies a medicine that is a restricted Schedule 3 poison by retail sale must — (a) record in an approved system the following information — (i) the date of sale; (ii) the name and address of the purchaser; (iii) if the medicine is intended for the use of a person other than the purchaser — the name and address of the person; (iv) the name and quantity of the medicine supplied; and (b) allocate to each sale a unique identification number or alpha‑numerical code, and record the number or code in the system. (3) The information recorded under subregulation (2) must — (a) be kept for at least 2 years from the date on which the medicine is supplied; and (b) be produced for inspection on the request of the CEO or an investigator. [Regulation 142 amended: SL 2020/214 r. 4.] ##### 143. Record of administration or supply of medicine that is Schedule 4 or 8 poison (1) An authorised health professional who administers or supplies a medicine that is a Schedule 4 or 8 poison for the treatment of a person or an animal must ensure that the following information is recorded on the clinical record for the person or animal — (a) the name, quantity, strength and form of the medicine supplied or administered; (b) the address of the person treated or the name and address of the owner of the animal treated; (c) the date on which the medicine is supplied or administered; (d) if the medicine is supplied in accordance with a prescription — (i) the prescription reference number; and (ii) the date of issue of the prescription; (e) if the medicine is administered or supplied for the treatment of a person — the date of birth of the person; (f) if the medicine is a Schedule 4 reportable poison or a Schedule 8 poison — the name and address of the prescriber. (2) The information recorded under subregulation (1) must — (a) be provided to the CEO in the manner and form and at the times specified by the CEO; and (b) in the case of a medicine that is a Schedule 4 poison — be kept for at least 2 years from the date on which the medicine is administered or supplied; and (c) in the case of a medicine that is a Schedule 8 poison — be kept for at least 5 years from the date on which the medicine is administered or supplied; and (d) be produced for inspection on the request of the CEO or an investigator. [Regulation 143 amended: SL 2020/214 r. 5; SL 2024/265 r. 26.] ##### 143A. Record of prescription of medicine that is Schedule 4 or 8 poison (1) An authorised health professional who prescribes a medicine that is a Schedule 4 or 8 poison for the treatment of a person or an animal must ensure that the following information is recorded on the clinical record for the person or animal — (a) the name and address of the authorised health professional; (b) the name, quantity, strength and form of the medicine prescribed; (c) if the medicine is prescribed for the treatment of a person — (i) the name and address of the person; and (ii) the date of birth of the person; (d) if the medicine is prescribed for the treatment of an animal — (i) the name and address of the owner of the animal; and (ii) the species of the animal; (e) the date on which the medicine is prescribed. (2) The information recorded under subregulation (1) must — (a) be provided to the CEO in the manner and form and at the times specified by the CEO; and (b) in the case of a medicine that is a Schedule 4 poison — be kept for at least 2 years from the date on which the medicine is prescribed; and (c) in the case of a medicine that is a Schedule 8 poison — be kept for at least 5 years from the date on which the medicine is prescribed; and (d) be produced for inspection on the request of the CEO or an investigator. [Regulation 143A inserted: SL 2020/214 r. 6; amended: SL 2024/265 r. 27.] ##### 144. Requirement to keep register of Schedule 9 poisons and medicines that are Schedule 8 poisons authorised person means each of the following — (a) a person authorised under a licence or a permit to manufacture, supply or use a Schedule 9 poison or a medicine that is a Schedule 8 poison and who has possession of the poison or medicine for that purpose; (b) a person authorised by a professional authority to manufacture or supply a medicine that is a Schedule 8 poison and who has possession of the medicine for the purpose of that supply; recordable event, in relation to a Schedule 9 poison or a medicine that is a Schedule 8 poison, means each occasion on which the poison or medicine is received, supplied, used, administered or transported by or on behalf of an authorised person. (2) An authorised person must keep a register of the Schedule 9 poisons and the medicines that are Schedule 8 poisons manufactured, received, stored, supplied, administered or transported by or on behalf of the person. (3) The register must be — (a) kept for each premises at which the authorised person manufactures, or from which the authorised person supplies, a Schedule 9 poison or a medicine that is a Schedule 8 poison; and (b) kept on the premises to which it relates. (4) The following information must be recorded in the register — (a) the name, quantity, form and date of manufacture of a Schedule 9 poison or a medicine that is a Schedule 8 poison that is manufactured; (b) for each recordable event for a Schedule 9 poison or a medicine that is a Schedule 8 poison — (i) the name, quantity, strength and form of the poison or medicine involved; and (ii) the date of the recordable event; and (iii) the name and address of each other person involved in the recordable event; and (iv) if the recordable event involves the supply or administration of a poison or medicine — the name of the person who issued the prescription, order or other authority for the poison or medicine; and (v) if the recordable event involves the supply or administration of a medicine in accordance with a prescription — the prescription reference number of the prescription; and (vi) if the recordable event involves the supply of a medicine or poison on an order or other authority — the identifying number for the order or other authority on which the poison or medicine is supplied; and (vii) the quantity of the poison or medicine remaining on hand after the recordable event; (c) for each inventory made by the authorised person under regulation 148 — (i) the date the inventory is made; and (ii) the name, quantity, strength and form of the Schedule 9 poisons and medicines that are Schedule 8 poisons at the premises for which the register is kept when the inventory is made. (5) Information must be recorded in a register as follows — (a) in the case of information referred to in subregulation (4)(b) — at the time a recordable event occurs; (b) in the case of information referred to in subregulation (4)(c) — on the day an inventory is made. (6) Each entry in a register must be signed by the authorised person who is responsible for keeping the register. (7) Information on a register must be kept for at least 5 years from the date on which the information is recorded. (8) A register for premises must be kept in such a way that the quantity of each Schedule 9 poison and each medicine that is a Schedule 8 poison at the premises at any time is clearly identifiable. (9) An authorised person must — (a) provide details of the register to the CEO in the manner and form and the times specified by the CEO; and (b) produce the register for inspection on the request of an investigator. ##### 145. Destruction of Schedule 9 poison or medicine that is Schedule 8 poison qualified person means a person who is in one or more of the following categories — (a) a health professional; (b) an investigator; (c) a police officer. (2) A Schedule 9 poison or a medicine that is a Schedule 8 poison must not be wilfully destroyed unless — (a) it is destroyed by or on behalf of — (i) a qualified person who is authorised to possess the poison or medicine; or (ii) a licensee or a permit holder who is authorised to possess the poison or medicine; and (b) the destruction is witnessed by a qualified person who is not the person by or on behalf of whom the medicine or poison is destroyed. (3) A person who wilfully destroys a Schedule 9 poison or a medicine that is a Schedule 8 poison must keep a register of the poisons or medicines destroyed by or on behalf of the person. (4) The following information must be recorded in the register — (a) the name, contact details and signature of the person by or on behalf of whom the poison or medicine is destroyed; (b) details of the basis on which the person is authorised to destroy the medicine or poison or have it destroyed; (c) the date of destruction; (d) the name, quantity, strength and form of the poison or medicine destroyed; (e) the reason for destruction; (f) the method of destruction; (g) the name, contact details and signature of the witness to the destruction and details of the category under which the witness is a qualified person. ##### 146. Registers generally (1) A register kept for the purposes of regulation 144(2) or 145(3) must be kept in a manner and form approved by the CEO. (2) The CEO must not approve the keeping of a register by means of an electronic system unless the CEO is satisfied that the system will comply with the requirements in regulation 147. ##### 147. Requirements for electronic register access code, for a person, means a password or other means by which the person gains access to a register; authorised person, in relation to a register, means the person who is required under regulation 144(2) or 145(3) to keep the register; register means a register kept electronically for the purposes of regulation 144(2) or 145(3); system identifier, of a person, means the code or identifier by which the identity of the person is recorded by a register. (2) The requirements for an electronic system for the keeping of a register are as follows — (a) entries in the register cannot be deleted; (b) entries in the register cannot be made by any person who does not use a system identifier issued by the authorised person for the register; (c) information recorded or stored in the register — (i) remains in the form in which it is originally recorded; and (ii) is capable of being reproduced on paper in a written form; (d) a system identifier must be used in combination with an access code for the person to whom the system identifier is issued; (e) the system identifier of a person is automatically recorded in the register when the person makes an entry in the register; (f) a record is kept of the system identifiers issued to persons who use the system in a form that cannot be changed. ##### 148. Inventory of Schedule 9 poisons and medicines that are Schedule 8 poisons (1) An authorised person who is required under regulation 144(2) to keep a register of Schedule 9 poisons or medicines that are Schedule 8 poisons in respect of premises must, at intervals of not more than 1 month, make an inventory of the Schedule 9 poisons or medicines that are Schedule 8 poisons at the premises. (2) If the inventory does not agree with the information recorded under regulation 144(4)(b)(vii) in the register for the premises at the time the inventory is made, the authorised person must immediately give written notice of the discrepancy to the CEO. ## Part 12A — Infringement notices [Heading inserted: SL 2024/224 r. 4.] ##### 148A. Prescribed offences and modified penalties (1) The offences specified in Schedule 4 to these regulations are offences for which an infringement notice may be issued under the *Criminal Procedure Act 2004* Part 2. (2) The modified penalty specified opposite an offence in Schedule 4 to these regulations is the modified penalty for that offence for the purposes of the *Criminal Procedure Act 2004* section 5(3). [Regulation 148A inserted: SL 2024/224 r. 4.] ##### 148B. Authorised officers and approved officers (1) The CEO may, in writing, appoint persons or classes of persons to be authorised officers or approved officers for the purposes of the *Criminal Procedure Act 2004* Part 2 in relation to infringement notices issued under that Part for an offence specified in Schedule 4 to these regulations. (2) The CEO must issue to each person appointed as an authorised officer under subregulation (1) a certificate, badge or identity card identifying the officer as a person authorised to issue infringement notices. (3) A person appointed as an authorised officer under subregulation (1) may show that they are an authorised officer by producing the certificate, badge or identity card issued to them under subregulation (2). [Regulation 148B inserted: SL 2024/224 r. 4.] ##### 148C. Forms For the purposes of the *Criminal Procedure Act 2004* Part 2, the forms set out in Schedule 5 to these regulations are prescribed in relation to the matters specified in those forms. [Regulation 148C inserted: SL 2024/224 r. 4.] ## Part 12B — Miscellaneous [Heading inserted: SL 2024/224 r. 4.] ##### 148D. Term used: Schedule 6 nitrous oxide